.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Zolpidem tartrate - Generic Drug Details

« Back to Dashboard
Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Torrent Pharms, Dr Reddys Labs Inc, Sandoz, Sanofi Aventis Us, Par Form, Teva, Biovail Labs Intl, Aurobindo Pharma, Roxane, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Purdue Pharma, Hikma, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Labs, Apotex Inc, Lupin Ltd, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Yung Shin Pharm, Amherst Pharms Llc, Meda Pharms, and Novel Labs Inc, and is included in thirty-eight NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fifteen patent family members in thirty-five countries.

There are thirty-one drug master file entries for zolpidem tartrate. Sixty-three suppliers are listed for this compound.

Summary for Generic Name: zolpidem tartrate

Tradenames:7
Patents:10
Applicants:34
NDAs:38
Drug Master File Entries: see list31
Suppliers / Packagers: see list63
Bulk Api Vendors: see list30
Clinical Trials: see list99
Patent Applications: see list592
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL078426-001May 15, 2007RXNo► subscribe► subscribe
Meda Pharms
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009RXNo8,512,747► subscribe ► subscribe
Anchen Pharms
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL078148-002Apr 14, 2011RXNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-001Dec 16, 19924,382,938*PED► subscribe
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-002Dec 16, 19924,382,938*PED► subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 20054,382,938*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: zolpidem tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,454,996Pharmaceutical composition for the treatment of acute disorders► subscribe
9,078,816Buccal, polar and non-polar spray containing ondansetron► subscribe
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: zolpidem tartrate

Country Document Number Estimated Expiration
Japan2002531499► subscribe
Japan2008517988► subscribe
Spain2433930► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ZOLPIDEM TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636Luxembourg► subscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015 00004Denmark► subscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
00714Netherlands► subscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc